Symptomatic Treatment of Mild COVID-19 with Vitex negundo (NIRPROMP formulation): A Randomized, Controlled Clinical Trial

Abstract

There are few drugs available for the early treatment of mild COVID-19 infection. This study aimed to assess the efficacy and safety of Lagundi (Vitex negundo) tablets and syrup in patients with mild COVID-19 without comorbidities. This was a 2-stage multicenter parallel, randomized clinical trial. Stage 1 was a dose-finding study comparing high with standard-dose Lagundi. Stage 2 was the efficacy study using the dose chosen from stage 1 vs. placebo. Outcome measures included symptom scores, clinical recovery time, disease progression, global evaluation scales (GES), and time to negative RT-PCR. Lagundi and placebo treatments were given for 10 days. For stage 1, there was no significant difference in the time to recovery and global evaluation scales for the two dosage groups (n=75). Standard dose was chosen for the 2^nd stage. In stage 2, baseline characteristics between Lagundi 600 mg three times a day (n=101) and the placebo (n=99) were not significantly different except for BMI. Total symptom scores (-8.0,95%:CI: -13.37,-2.62) and anosmia scores (-4.17,95%CI:-6.35,-1.98) at endline were significantly lower in the Lagundi group compared to the placebo when controlling for visit date and baseline scores signifying greater relief for Lagundi.  Scores for other symptoms were lower in the Lagundi group but were not significant. Physician- and patient-rated GES scores were higher for the Lagundi group than placebo (suggesting more relief) but were not statistically significant. RT PCR showed no significant differences between Lagundi and placebo on mean cycle threshold values for days 4, 8, and 12. The mean recovery time (overall and for symptoms) was not significantly different between the two groups. Adverse events were not significantly different between the intervention and placebo.